SN EN ISO 14602:2012

Foreword
Introduction
1 Scope
2 Normative references
3 Definitions
4 Intended performance
5 Design attributes
6 Materials
7 Design evaluation
8 Manufacturing
9 Sterilization
10 Packaging
11 Information supplied by the manufacturer
Annex A (informative) ISO Standards referring to implants and
associated instruments found acceptable through clinical use
for given applications in osteosynthesis
Annex B (informative) ISO standards referring to materials
found acceptable through proven clinical use
Annex C (informative) Standards relating to testing and
design evaluation
Annex ZA (informative) Clauses of this European Standard
addressing essential requirements or other provisions of
EU Directives

Defines particular requirements for non-active surgical implants for osteosynthesis. Supplies particular requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging and information supplied by the manufacturer.